Senior CAR-T GMP QA Specialist

Skills Alliance Enterprise; Stevenage; On-site; GBP 42,000 - 64,000; Full time

Job summary

Skills Alliance Enterprise is seeking a Quality Assurance professional to support the Product Delivery team in autologous CAR-T manufacturing under GMP. You will ensure compliant, timely batch release and act as QA liaison across Manufacturing, QC and QP stakeholders.

Ideal candidates have 2–5 years in sterile pharmaceutical QA, a BSc in life sciences or MSc in pharma/immunology, and strong GMP knowledge with proven documentation and cross-functional communication skills.

Qualifications

• Experience in sterile pharma manufacturing quality assurance.
• 2–5 years in QA for sterile manufacturing.
• GMP documentation experience.

Responsibilities

• Provide day-to-day QA support to GMP manufacturing operations for autologous CAR T-cell products.
• Review Batch Manufacturing Records and Quality Control records to support batch certification and product release.
• Manage deviations, investigations, OOS/OOT results, environmental monitoring excursions, CAPAs and change controls.
• Assess quality issues during manufacturing, ensuring appropriate investigation, documentation, escalation and resolution.
• Act as a QA point of contact for Manufacturing, QC and other cross-functional stakeholders, escalating significant quality issues to Quality leadership and Qualified Persons (QPs).
• Support the maintenance of batch and patient-specific product traceability throughout the manufacturing and release process.
• Author, review and approve GxP documentation in accordance with established procedures and regulatory requirements.
• Support the effective operation and continuous improvement of the Pharmaceutical Quality System (PQS), ensuring quality activities are progressed and closed within appropriate timelines.
• Support regulatory inspection readiness and other QA compliance activities as required.

Skills

GMP knowledge

QA in GMP

Deviation management

Batch records review

Cross-functional comms

CAR-T familiarity

Education

BSc, Life Sciences

MSc, Pharma/Immunology

Job description

Skills Alliance Enterprise is seeking a Quality Assurance professional to support the Product Delivery team in autologous CAR-T manufacturing under GMP. You will ensure compliant, timely batch release and act as QA liaison across Manufacturing, QC and QP stakeholders.

Ideal candidates have 2–5 years in sterile pharmaceutical QA, a BSc in life sciences or MSc in pharma/immunology, and strong GMP knowledge with proven documentation and cross-functional communication skills.